Catheter RF Perforation Device Positional Markers
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Solution Overview
Problem
Current methods for fluoro-less cardiac procedures lack effective positional cues, leading to potential misinterpretation and confusion during medical procedures, as simple solid markers provide limited information and may be perceived incorrectly by users.
Innovation Solution
A transseptal access and crossing system that includes an outer guide member and a radiofrequency perforation device with distal, intermediate, and proximal markers, which are positioned and sized to provide clear indications of the radiofrequency perforation device's location relative to the outer guide member, using contrasting colors and potentially tactile markers.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If fluoroscopic imaging is used to guide catheter positioning, then positioning accuracy is improved, but radiation exposure to the patient increases
Solution Approach 1:
The patent introduces markers as an intermediary visual aid that allows physicians to determine catheter position without relying on fluoroscopic imaging. The markers serve as a mediator between the catheter and the physician's visual assessment, enabling fluoro-less procedures while maintaining positioning accuracy
Solution Approach 2:
The patent replaces the mechanical/radiological system of fluoroscopic imaging with a visual system using markers. Instead of using X-rays to visualize catheter position, the system uses optically visible markers that can be seen directly during the procedure, eliminating the need for continuous fluoroscopic exposure
2Device complexity
If simple solid markers are used on guidewires, then device complexity is reduced, but information clarity and user understanding deteriorate
Solution Approach 1:
The patent divides the marker system into multiple distinct markers positioned at specific locations along the catheter (distal marker at the tip, intermediate marker at the radiopaque tip, proximal marker near the hub). Each marker serves a specific function and provides different positioning information, allowing physicians to determine catheter depth and orientation more accurately without excessive complexity
Solution Approach 2:
The patent applies different marker characteristics at different locations along the catheter. The distal marker is positioned to indicate tip location, the intermediate marker indicates radiopaque tip position, and the proximal marker indicates hub proximity. Each marker has specific visual properties (color, size, shape) optimized for its local function, improving overall information clarity
Data Source
AI summary
A transseptal access and crossing system for perforating a septum in a patient's heart includes an outer guide member having a distal end, a proximal hub, and a lumen extending therebetween. A radiofrequency perforation device includes a distal tip and a proximal portion. The radiofrequency perforation device is configured to translate within the lumen. The radiofrequency perforation device proximal portion includes a distal marker, an intermediate marker, and a proximal marker. Each of the distal marker, the intermediate marker, and the proximal marker are positioned and sized to provide an indication of the location of the distal tip of the radiofrequency perforation device in relationship to the distal end of the outer guide member.


